A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- FHI 360
- 入组人数
- 724
- 试验地点
- 1
- 主要终点
- pregnancy
研究概览
简要总结
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
详细描述
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan. It will be conducted in close collaboration with the Pakistan MoH and Marie Stopes Society, Pakistan in several MoH-affiliated and Marie Stopes Society clinics that have experience with implants and sufficient expected flow of implant users per month. We will enroll a total of 600 women divided into two cohorts in this one-year prospective study:
- a prospective cohort consisting of 300 women who will be followed-up 3 and 12 months after enrolment; and
- a surveillance cohort of 300 women who will report back to the clinic during 12 months after enrolment only if they have complications, medical problems, pregnancy, or want to remove the implant
The main study outcomes are pregnancy, immediate and delayed complications associated with insertion or removal, adverse events, early discontinuation and reasons for discontinuation, and level of women's satisfaction with Femplant services.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be eligible for inclusion, a woman must:
- •be aged 18-44 years, inclusive
- •be willing to sign an informed consent document
- •agree to return for follow-up visits
- •have decided to receive Femplant as a method of contraception and met the clinic criteria for eligibility of this method of contraception
排除标准
- 未提供
结局指标
主要结局
pregnancy
时间窗: 12 months
measure number of pregnancies while using implant
Immediate and Delayed Complications
时间窗: 12 months
Measure Immediate and delayed complications associated with insertion or removal of implant
Adverse events
时间窗: 12 months
to record any adverse events associated with the implant
Measure number of participants who discontinue from the study
时间窗: 12 months
Measure number of participants who discontinue from the study and the reasons for discontinuation
次要结局
未报告次要终点